Events

Rappel de PercuNav Field Generator Stand

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems North America Co. Phillips.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58429
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2219-2011
  • Date de mise en oeuvre de l'événement
    2011-04-01
  • Date de publication de l'événement
    2011-05-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99329
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Computed Tomography X-Ray System - Product Code JAK
  • Cause
    The percunav field generator stand could tip over during set up, during use, or during transport.
  • Action
    On 4/4/11, Philips Healthcare began sending out the URGENT-Medical Device Correction notification letter to their consignees. Philips informed their customers of a potential tipping hazard of the PercuNav Field Generator Stand. The notification letter also provides instructions to customers to ensure the articulating Mounting Arm is positioned so the Field Generator is not further than the specified distance from the back of the clamp on the stand's central pole during set up or during use. Customers are instructed to apply a provided label on stand to warn of a potential for tipping due to excessive force. For transport, customers are instructed to remove the Field Generator from the Mounting Arm and place the Field Generator in the storage compartment on the system cart. The Mounting Arm should then be collapsed and folded into a 90 degree angle. Customers are informed that a Philips field service representative will contact them to schedule installation of a service kit on the stand, free of charge, once service kits are available. Customers can call Philips Customer Service at 1-866-767-7822 and reference to FCO 79500197 for any questions about this recall.

Device

PercuNav Field Generator Stand
  • Modèle / numéro de série
    System Code Serial Numbers:  03B8Y3, 20071000005, 20071000006, 20071000007, 20071000008, 20071000009, 20071000010, 20081000011, 20081000013, 20091000019, 20091000020, 20091000021, 20091000022, 20091000023, 02RCHF, 02X3NK, 034K1R, 039VDK, 039W1H, 03B4F3, 03B59R, 03B8MW, 03B8N0, 03B8QR, 03B8XX, 03B8XY, 03B8XZ, 03B8Y0, 03B8Y1, 03B8Y4, 03B8Y5, B0091T, B009BJ, B009HV, B009VJ, B00DDJ, B00DQ2, B00DQX, B00DQZ, B00DRF, B00DRP, B00DT7, B00DXM, B00DY0, B00F1Q, B00F3H, B00F3M, B00HKW, B00HKZ, B00HV4, B00HV7, B00HW3, B00HZR, B00J05, B00P3X, B00P3Y, B00P59, B00P5P, B00PB4, B00PJJ, B00PPP, B00PQ7, and P002A20090500005.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Austria, Belgium, China, France, Germany, Hong Kong, India, Korea, Netherlands, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom.
  • Description du dispositif
    PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. || Designed to be used only with the PercuNav" image guided intervention system. The Field Generator Stand (with articulating Mounting Arm) is used to position the Field Generator near the area of interest.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Adresse du fabricant
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA